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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003157
Receipt No. R000003826
Scientific Title Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regimen
Date of disclosure of the study information 2010/02/10
Last modified on 2014/08/24

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Basic information
Public title Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regimen
Acronym Phase II study of peptide vaccination in bladder cancer patients progressing after chemotherapy
Scientific Title Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regimen
Scientific Title:Acronym Phase II study of peptide vaccination in bladder cancer patients progressing after chemotherapy
Region
Japan

Condition
Condition Bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to bladder cancer patients progressing after first-line platinum-containing regimen. The aim of the study is to investigate the safety, immunological responses and antitumor activity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of antitumor activity (progression free survival) of peptide vaccination.
Key secondary outcomes 1.Evaluation of response rate and long-term prognosis (overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0).
3.Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm 1: personalized peptide vaccine plus best supportive care (BSC)
(1st treatment: total 8 times, every weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
Day 8, 15, 22, 29, 36, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: First evaluation.
The 1st treatment (total 8 times, every weeks) is finished. Clinical response is evaluated by RESIST criteria.
(2nd treatment: total 4 times, every 2 weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides.
Day 15, 29, 43 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 43: Second evaluation.
The 2nd treatment (total 4 times, every 2 weeks) is finished. Clinical response is evaluated by RESIST criteria.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.
(Follow-up)
Duration of follow-up is 8 months after protocol treatment.
Interventions/Control_2 Arm 2: Best supportive care (BSC)
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, orticosteroids, and transfusion) for 16 weeks.
Day 57:First evaluation.
Clinical response is evaluated by RESIST criteria.
Day 113: Second evaluation
Clinical response is evaluated by RESIST criteria.
(Follow-up)
Duration of follow-up is 8 months after protocol treatment.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects must satisfy the following conditions.
1) Patients require histologically confirmed locally advanced or metastatic bladder cancer and documented after first-line platinum containing chemotherapy.
2) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
3) Patients in arm 1 must have IgG reactive to at least two of peptide candidates.
4) Prior treatment are allowed and must
complete 4 weeks before random
assignment with full recovery of related
toxicity.
5) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC > 2,500/mm3
Lymphocyte > 1,000/mm3
Hb > 8.0g/dl
Platelet > 100,000/mm3
Serum Creatinine < 2 x upper limit of normal
Total Bilirubin > 2 x upper limit of normal
8) Patients require to have adequate organ function.
9) Patients must be more 18 year-old.
10) Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Noguchi
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy, Clinical Research Division, Department of Urology
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7989
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy, Cancer Vaccine Division
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7572
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hirosaki University , Dokkyou University, Kitasato University, Kinki University, Okayama University, Kyushu University, Fukuoka University, Kumamoto University
Name of secondary funder(s) Kurume University

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 久留米大学病院(福岡県)、弘前大学病院(青森県)、獨協医科大学越谷病院(埼玉県)、北里大学病院(神奈川県)、近畿大学病院(大阪府)、岡山大学病院(岡山県)、九州大学病院(福岡県)、福岡大学病院(福岡県)、熊本大学病院(熊本県)
Kurume University Hospital, Hirosaki University Hospital, Dokkyo University Koshigaya Hospital, Kitasato University Hospital, Kinki University Hospital, Okayama University Hospital, Kyusu University Hospital, Fukuoka University Hospital, Kumamoto University Hospital

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 09 Day
Last modified on
2014 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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